PROTOCOL REVIEW AND MONITORING SYSTEM: PROJECT SUMMARY The Herbert Irving Comprehensive Cancer Center (HICCC) Protocol Review and Monitoring System (PRMS) is responsible for independent scientific evaluation, prioritization, and monitoring of all cancer clinical research studies conducted at Columbia University Irving Medical Center (CUIMC). The PRMS is independent of and complements the activities of the Institutional Review Boards (IRBs) and HICCC Data Safety and Monitoring Committee (DSMC). The PRMS encompasses activities of the HICCC Disease Based Teams, Feasibility Committee, and Protocol Review and Monitoring Committee (PRMC). Although independently managed, these entities maintain close interactions and collaborations. The Specific Aims of the HICCC PRMS are the following: (1) Provide scientific review and prioritization of all applicable cancer-related clinical research protocols within the HICCC, (2) Monitor the progress of ongoing studies to ensure that accrual is sufficient to meet scientific objectives, (3) Determine whether trials should continue or close for lack of scientific progress, and (4) Assess and implement the recommendations of the Data Safety and Monitoring Committee (DSMC) regarding issues that may affect the scientific integrity of interventional trials. The process for review of cancer clinical research studies through the PRMS are as follows: ? Disease Based Teams: Assess new trials for scientific value, fit and prioritization with existing disease-based research portfolios ? Feasibility Committee: Review protocol feasibility to determine that adequate resources are in place prior to PRMC review ? PRMC: Evaluate interventional protocols for scientific merit, innovation, and statistical soundness so as to assess their priority at initial submission. The PRMC also assess the scientific and accrual progress of interventional cancer trials at the time of continuing review. In 2018, the PRMC monitored 381 active interventional studies. The PRMC reviewed 128 new studies (full board review: 96; expedited review: 32) and 448 amendments. 1